Vaccine shipments raise temperature requirement questions

Operators are looking to mitigate the challenges inherent in shipping large quantities of dry ice as mass shipments of Pfizer and BioNTech’s COVID-19 vaccine began in the U.S. this week. The Softbox containers selected by Pfizer prevent the high sublimation rates that can endanger crew members with CO2 gas, but the containers have arrived at ultra-cold temperatures outside proven usability ranges in some initial shipments to California and Alabama. [caption id="attachment_93736" align="alignright" width="449"] The packaging used by Pfizer was developed by Softbox. Photo/Alaska Airlines[/caption] The Pfizer vaccine requires a storage temperature of around -70 C, the coldest among major vaccines in advanced clinical trials. Such cold shipments must be packaged and transported with dry ice, which is solid carbon dioxide; rather than rely on more common temperature-controlled ULDs utilized for air cargo transport, Pfizer has opted for packages produced by Softbox. According to a Boeing media briefing this week, the Softbox containers are so thermally efficient that Boeing has issued new guidance around the maximum amounts of dry ice that can be utilized on its aircraft, as the lower sublimation rate slows CO2 buildup, compared to other containers. One apparent side effect of the efficient packages is that some vaccine doses delivered this week to California and Alabama fell to -92 C and had to be returned to Pfizer, according to a media briefing Wednesday from Army General Gustave Perna, who oversees Operation Warp Speed. Perna said the vaccines were moving in the normal supply chain when the temperature deviation was discovered. It is unclear whether the lower temperatures affect the vaccine’s safety or usability, since the rapid development of the vaccine has left some unanswered questions. “I think, over time, the Pfizer vaccine will get to a different temperature range,” Larry St. Onge, president for life sciences and health care at DHL, told Air Cargo World . “It’s just a matter of gathered data.” According to St. Onge, pharmaceutical companies “often gather scientific data about what happens to the drug or the active ingredient, based on exposure to different temperature ranges” during vaccine trials. Due to the accelerated development time frame of Pfizer’s vaccine, there has likely not been sufficient data collected to determine the full range of temperatures under which the vaccine can be stored. St. Onge said this is likely prompting Pfizer to ensure the “most stringent scenario” for transportation requirements. While St. Onge added that DHL regularly transports pharma products under even more stringent requirements, vaccines that don’t require dry ice to transport can be easier to ship as other cold transport materials are not classified as dangerous goods. According to the Boeing briefing, other vaccines, such as the one in development by biotech company Moderna, will use gel packs rather than dry ice for temperature control during transport. Although using gel packs will not require adherence to dry ice limitations for safe loading, they still present their own supply chain challenges. To maintain the cold temperatures, gel packs and phase-change materials require preconditioning ahead of transport to the necessary temperature, at which time the materials will maintain the temperature for “four to five days,” said St. Onge. “Then, the challenge is just ensuring that you can get preconditioned material that goes inside the containers.” Dry ice must be supplied for shipments of Pfizer’s vaccine, and resupplied if the containers are used for storage beyond the initial transport. According to confidential re-icing instructions Pfizer sent to end users of the vaccine that were seen by Air Cargo World , Pfizer has advised that local dry ice suppliers should be used for re-icing but, depending on the destination of the shipments, that may not be feasible. Many locations will not have local storage at the required temperature and, according to a fact sheet from Pfizer, the boxes can be used as temporary storage for up to 30 days by re-icing them every five days. According to St. Onge, Pfizer has “taken every step” to ensure dry ice will be replenished, and will ship dry ice to vaccination centers for replenishment, if necessary.

Vaccine shipments raise temperature requirement questions

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